FDA Registration
Active
🇺🇸 United States
2SAN LLC
Reg #: 3025041446
·
FEI: 3025041446
·
Expires 2026
Products
17
Proprietary Names
12
Establishment Types
1
Classifications
17
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Registration Details
- Registration Name
- 2SAN LLC
- Registration Number
- 3025041446
- FEI Number
- 3025041446
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1330 Avenue of the Americas
- City
- New York
- State
- NY
- ZIP
- 10019
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231045
Owner / Operator
- Firm Name
- 2San LLC
- Operator Number
- 10088220
- Address
- 1330 Avenue of the Americas
- City
- New York
- State
- NY
- Postal Code
- 10019
- Country
- US
- Correspondent
- Chelsea Tooze
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2023-06-12 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2024-01-10 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2024-01-10 |
| Coronavirus Antigen Detection Test System. | QKP | Class N | Unknown | No | 2024-10-23 |
| Reagent, Occult Blood | KHE | Class 2 | Hematology | No | 2023-06-12 |
| Test, Barbiturate, Over The Counter | PTH | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Propoxyphene, Over The Counter | QBF | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Opiates, Over The Counter | NGL | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Methamphetamine, Over The Counter | NGG | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Cocaine And Cocaine Metabolites, Over The Counter | NFY | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Benzodiazepine, Over The Counter | NFV | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Methadone, Over The Counter | PTG | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Cannabinoid, Over The Counter | NFW | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Tricyclic Antidepressants, Over The Counter | QAW | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Test, Amphetamine, Over The Counter | NFT | Class 2 | Clinical Toxicology | No | 2023-06-12 |
| Enzyme Immunoassay, Phencyclidine | LCM | Class U | Unknown | No | 2023-06-12 |
| Enzyme Immunoassay, Opiates | DJG | Class 2 | Clinical Toxicology | No | 2024-01-10 |
Proprietary Names
2San Vaginal pH Rapid Test Cassette
2San Urinary Tract Infection (UTI) Test
Speedy Swab Rapid COVID-19 + Flu A&B Antigen Self-Test
Speedy Swab Rapid COVID-19 Antigen Self-Test
2San Colorectal Cancer Test
2San Home Drug Test - 4 Panel
2San Home Drug Test - 7 Panel
2San Home Drug Test - 1 Panel (THC)
2San Home Drug Test - 14 Panel
2San Home Drug Test - 1 Panel (COC)
2San Urinary Tract Infection Test
2SAN Fentanyl Urine Test Cassette
Establishment Types
Complaint File Establishment per 21 CFR 820.198